Yoga for Pain and Opioid Dependence

NCT01590251 | Completed Phase 1

• 1 other identifier: 1111009292
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.

Conditions

Chronic Pain; Opioid Addiction

Keywords

Pain; Addiction; Buprenorphine; Counseling; Methadone; Yoga

Outcome Measures

Primary Outcomes (2)

• Pain reduction

  Pain reduction will be measured by patient self-report using standard pain rating scales.

  8 weeks

• Reduce illicit opioid use

  Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.

  8 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

Gentle yoga for chronic pain and opioid dependence

Other: Yoga

Educational Counseling

ACTIVE COMPARATOR

Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.

Behavioral: Educational Counseling

Interventions

Yoga OTHER

Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.

Yoga

Educational Counseling BEHAVIORAL

One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.

Educational Counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Prescription opioid addiction or heroin addiction
• Moderate to severe chronic pain,
• Understands English

You may not qualify if:

• Current suicide or homicide risk
• Life threatening or unstable medical condition
• Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
• Pregnancy

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

MRU

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders; Pain; Behavior, Addictive

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Declan T Barry, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

US (1)